Pre-filled syringe safety devices and injectors, systems, and methods of use
A prefilled syringe safety device and injector for use with a syringe. The prefilled syringe safety device and injector includes a cartridge, a casing, a tube, a biasing member, a ring and a plunger slider. The cartridge supports the syringe therein. The cartridge is supported within the casing. The tube includes a tube distal end. The tube is slidably engaged with the cartridge and can be in an extended state and in a retracted state. When in the retracted state, the needle of the syringe extends beyond the tube distal end and the casing distal opening. The biasing member is engaged with the cartridge and the tube to bias the tube in the extended state. The ring includes a protrusion and is engaged with the tube and the biasing member. The protrusion is positioned within the track. The plunger slider engages with the plunger of the syringe.
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This application is a continuation of U.S. application Ser. No. 18/285,671, filed Oct. 5, 2023, which application is a national stage entry of PCT Application No. PCT/US2022/023878, filed Apr. 7, 2022, which PCT application claims the benefit of U.S. Provisional Application No. 63/172,512, filed Apr. 8, 2021. All the afore-mentioned applications are hereby incorporated by reference in their entireties into the present application for all purposes.
TECHNICAL FIELDThe present disclosure relates to a pre-filled syringe safety devices and injectors, systems, and methods of use. More particularly, the disclosure relates to pre-filled syringe safety devices and injectors, systems, and methods that are manually actuated to deliver a dose of a drug.
BACKGROUNDAuto-injectors are medical devices that deliver a single dose of a drug via an enclosed, spring-loaded syringe. Conventionally, auto-injectors are designed to be self-administered, but can be administered by others. Auto-injectors are relatively easy to administer as compared with a syringe and needle, which require dosing of the drug into the syringe. Auto-injectors can mitigate fears associated with seeing an exposed needle. But, some patients may also fear the abrupt stab of the needle from auto-injectors.
Despite auto-injectors and conventional syringes and needles, many patients still fear needle injections. The fear can be so great that some patients may even quit administering their medications due to problems they face with auto-injectors and other injection methods. This causes problems for physicians looking to maintain patients on injectable therapies, insurance companies covering patients requiring injectable therapies, and pharmaceutical companies looking to maintain patients on their medications.
It is with these thoughts in mind, among others, that aspects of the pre-filled syringe safety devices and injectors were conceived. By utilizing the pre-filled syringe safety devices and injectors described herein, patients will be more likely to maintain use of their medications as there will be less reasoning to stop taking their medications. Increased medication maintenance provides improved health outcomes for patients and improved experiences for all entities involved in the injection market.
SUMMARYAspects of the present disclosure includes an injector for use with a syringe having a plunger, a barrel, and a needle. The injector may include a cartridge, a casing, a tube, a biasing member, a ring, and a plunger slider. The cartridge may be configured to support the syringe therein. The casing includes a tubular body, a casing distal opening, an inner surface, an internal volume, a slider slot extending through the tubular body, and a track defined on the inner surface. The cartridge is supported within the casing. The tube includes a tube distal end, the tube slidably engaged with the cartridge and may be configured to be in an extended state and in a retracted state, wherein, in the retracted state, the needle of the syringe extends beyond the tube distal end and the casing distal opening. The biasing member may be engaged with the cartridge and the tube so as to bias the tube in the extended state. The ring may include a protrusion and be engaged with the tube and the biasing member. The protrusion may be positioned at least partially within the track. The plunger slider may have a first portion configured to engage with the plunger of the syringe within the internal volume of the casing. The plunger slider may have a second portion extending from the first portion and may be configured to be guided by the slider slot to depress the plunger of the syringe.
In certain instance, in the extended state, the tube extends distally past a tip of the needle.
In certain instance, the injector further may include a distal cap may be configured to couple to the tube distal end of the tube.
In certain instance, the distal cap includes a tubular extension having an opening sized to receive and secure a needle cap of the syringe therein such that removal of the distal cap from the tube distal end of the tube also removes the needle cap from the syringe.
In certain instance, the tube is may be configured to transition from the extended state, to the retracted state, and then to a locked extended state via interaction of the protrusion of the ring with the track.
In certain instance, the tube further includes a plurality of nubs at the distal tube end.
In certain instance, the casing further includes a longitudinal axis, the slider slot including a first section that is transverse to the longitudinal axis and a second section that is parallel to the longitudinal axis.
In certain instance, the casing further includes at least one viewing window extending through the tubular body.
In certain instance, the injector further may include the syringe being pre-filled with a dose of a substance.
In certain instance, the inner surface of the casing includes recess may be configured to receive and secure a flange of the syringe therein.
Aspects of the present disclosure may include an injector for use with a syringe having a plunger, a barrel having a flange, and a needle. The injector may include cartridge, a casing, a tube, and a plunger slider. The cartridge may be configured to support the syringe therein. The casing may include a body, a casing distal opening, an internal volume, and a slider slot extending through the body, the cartridge supported within the casing. The tube may include a tube distal end, the tube slidably engaged with the cartridge and biased so the tube distal end extends distally past a tip of the needle and distally past the casing distal opening, the tube may be configured to retract proximally upon overcoming a biasing force such that the needle of the syringe extends beyond the tube distal end and the casing distal opening. The plunger slider has a first portion that may be configured to engage with the plunger of the syringe within the internal volume of the casing, the plunger slider having a second portion extending from the first portion and may be configured to be along the slider slot to depress the plunger of the syringe.
In certain instance, the injector further may include the pre-filled syringe filled with a dose of a drug.
In certain instance, the outer tube further includes a channel guide defined on the inner surface of the outer tube, and the plunger slider further includes a protrusion, the protrusion may be configured to slide within the channel guide as the plunger slider guides depression of the plunger.
In certain instance, the casing includes a recess may be configured to support the flange of the barrel of the syringe.
In certain instance, the casing includes at least one window defined therein may be configured to provide a view of the barrel of the syringe.
In certain instance, the tube is in sliding relation to the cartridge, and wherein a biasing member is operably coupled between the tube and the cartridge.
In certain instance, the casing includes a track defined on an inner surface thereof, wherein the tube is in engagement with the track and the tube is may be configured to lock in an extended state.
In certain instance, the tube is may be configured to lock in an extended state only after the tube has been retracted relative to the casing.
In certain instance, the injector further may include a spring may be configured to provide the biasing force.
In certain instance, the spring provides a rotational bias to a lock ring coupled to the tube, the rotational bias may be configured to lock the tube in an extended state.
Aspects of the present disclosure may include a method of injecting a substance into an injection site of a patient. The method may include positioning a distal tube of an injector adjacent the injection site of the patient, the injection may include: a casing having an opening at a distal end thereof; a cartridge housed within the casing and supporting a syringe therein, the syringe enclosing the substance therein and including a barrel, a needle, and a plunger; a plunger slider engaged with the plunger of the syringe; the distal tube being slidingly coupled with the cartridge and biased into an extended position such that the distal tube extends over the needle and at least partially outwards from the opening at the distal end of the casing. The method may include depressing the distal tube against the injection site of the patient thereby causing the distal tube to be in a retracted position wherein the needle protrudes past the distal tube and into the injection site of the patient. The method may include distally advancing the plunger slider relative to the casing so as to depress the plunger within the barrel of the syringe to dispense the substance from the barrel, through the needle, and into the injection site of the patient. And, the method may include retracting the distal tube from the injection site of the patient thereby causing the distal tube to lock in the extended position.
In certain instance, the method further may include rotating the plunger slider relative to the casing prior to distally advancing the plunger slider relative to the casing.
In certain instance, distally advancing the plunger relative to the casing is restricted until the plunger slider is rotated.
In certain instance, the injector further includes a lock ring coupled to the distal tube, the lock ring including a feature that is guided by a corresponding feature on the casing to facilitate the distal tube being locked in the extended position.
In certain instance, the feature is a post, and the corresponding feature is a track formed on an inner side of the casing.
Aspects of the present disclosure can include an injector for use with a syringe having a plunger, a barrel, and a needle. In certain instances, the injector may include a cartridge, a casing, a tube, a biasing member, a ring and a plunger slider. The cartridge can support the syringe at least partially therein. The casing can include first and second openings, an inner surface, an outer surface opposite the inner surface, and a track defined on the inner surface. The casing can support the cartridge and the syringe. The tube can include a tube distal end. The tube can be slidably engaged with the cartridge and configured to extend and retract relative to the first opening of the casing. And, in a retracted state of the tube and with the casing supporting the cartridge and the syringe, the needle of the syringe can extend beyond the tube distal end and the first opening of the casing. The biasing member can be engaged with the cartridge and the tube so as to bias the tube in an extended state of the tube. The ring can include a protrusion and be engaged with the tube and the biasing member. The protrusion can be positioned at least partially within the track. The plunger slider can couple to the plunger of the syringe and be positioned at least partially outside the casing. When the plunger slider and the plunger of the syringe are coupled together, movement of the plunger slider and the plunger are fixed.
In certain instances, the cartridge and the casing are removably coupled together. In certain instances, the plunger slider extends at least partially through the second opening. In certain instances, the second opening extends through a sidewall of the casing. In certain instances, the second opening includes a linear section. In certain instances, the second opening includes a transverse section proximal to the linear section.
In certain instances, the inner surface defines an internal volume, and the plunger slider is configured to engage with the plunger of the syringe within the internal volume of the casing.
In certain instances, the protrusion of the ring is positioned at least partially within the track and is configured to lock the tube in the extended position after the tube has been in the retracted state.
In certain instances, the ring is configured to rotate relative to the tube at least partially when the ring is engaged with the tube and the biasing member.
In certain instances, the casing is configured to support the cartridge and the syringe in a fixed position relative to the casing during movement of the plunger slider.
In certain instances, the barrel of the syringe includes a flange, and the inner surface of the casing includes a structure configured to contact the flange of the barrel of the syringe in order to facilitate the fixed position of the syringe relative to the casing during movement of the plunger slider.
In certain instances, movement of the plunger slider is independent of movement of the tube. In certain instances, rotation of the plunger slider is inhibited once the plunger slider is moved distally.
In certain instances, the injector further comprising the syringe. In certain instances, the injector comprising a medicament housed within the syringe. In certain instances, the injector comprising a cap configured to releasably couple to an end of the casing.
In certain instances, the inner surface defines an internal volume, and the plunger of the syringe is positioned entirely within the internal volume of the casing.
In certain instances, the plunger slider comprises a proximal-facing engagement surface for use in at least assisting to moving the plunger slider distally. In certain instances, the plunger slider further comprises a side-facing engagement surface for use in at least assisting to moving the plunger slider distally.
In certain instances, a rate of movement of the plunger slider is manually controlled.
Aspects of the present disclosure can include a method of employing the injector having the casing supporting the cartridge and the syringe. The method may include applying the tube to an injection site thereby causing the tube to be in the retracted state thereby causing the needle to enter the injection site. The method may further include depressing the plunger slider at a user-controlled rate thereby causing dispensing of at least some of the medicament from the syringe into the injection site. The method may further include removing the tube from the injection site thereby causing the tube to be locked in the extended state shielding the needle.
In certain instances, depressing of the plunger slider is independent of applying the tube to the injection site. In certain instances, depressing the plunger slider is performed at a user-controlled amount in order to dispense all of the medicament. In certain instances, depressing the plunger slider is performed at a user-controlled amount in order to dispense less than all of the medicament.
The foregoing and other objects, features, and advantages of the present disclosure set forth herein will be apparent from the following description of particular embodiments of those inventive concepts, as illustrated in the accompanying drawings. It should be noted that the drawings are not necessarily to scale; however the emphasis instead is being placed on illustrating the principles of the inventive concepts. Also, in the drawings the like reference characters may refer to the same parts or similar throughout the different views. It is intended that the embodiments and figures disclosed herein are to be considered illustrative rather than limiting.
The injector 100 as described herein allows for a pre-filled syringe to be loaded into the device for injection of a dose of a substance. The injector described and shown herein permits a user to inject the needle into an injection site at his or her own pace, and then manually inject the medication. This is different than conventional auto-injectors, which inject and dispense medication in a single step. With the injector 100 described herein, the needle may be shielded by a portion the device before and after use. And after use, the needle may be locked from further exposure outside of the device. Thus, injection of the substance is performed manually by the user after the needle is exposed (and injected) into an injection site. The device may also inhibits dispensing of the substance from the pre-filled syringe until the needle is exposed.
The pre-filled syringe includes a barrel holding a substance (e.g., drug), a plunger slidingly engaged with the barrel, and a needle coupled to the barrel opposite the plunger. The barrel may also include a flange or projection at a proximal end thereof.
Referring to
The injector 100 further includes a cap 116 that is coupled to the tube 114. The cap 116 may be sized to also couple to a needle cap of the syringe (not shown) that covers the needle. Conventionally, pre-filled syringes are manufactured with a needle cap in place to guard the needle. In this way, the injector 100 can be assembled into an injector system in a sterile environment with the needle cap in place and with the cap 116 sized to couple to the needle cap. Then, upon removal of the cap 116 from the tube 114, the cap 116 also removes the needle cap.
The injector 100 further includes a plunger slider 118 near the proximal end 102 thereof. The plunger slider 118 is engaged with the plunger of the syringe, which is housed or enclosed within the injector 100. As will be described in this application in reference to subsequent figures, the plunger slider 118 is rotatable transversely to the longitudinal axis 106 and, then, it is distally depressible so as to dispense the substances within the syringe.
As best seen in
Also at the proximal end of the first casing 110 is a plunger guide recess 134 defined on an inner surface 142 of the first casing 110. The recess 134 does not extend through the entirety of the first casing 110. However, in alternative embodiments, the recess 134 may extend through an entirety of the first casing 110. The recess 134 includes a transverse section 136 (also referred to as a horizontal section) that is also partially defined on the second casing 112 (as shown in
As seen in
At the distal end, the first casing 110 includes a track or guide 148 defined within the inner surface 142. The track 148 is a recess defined within the inner surface 142 that is sized and shaped to receive and guide the protrusion on the lock ring 126 during retraction and extension of the tube 114 relative to the cartridge 122 and the first casing 110. The track 148 includes a starting point 158 and a terminus 160. The track 148 further includes a first longitudinal section 150 that is contiguous with a transverse section 152. The transverse section 152 is contiguous with a second longitudinal section 154 that includes an arched path. The second longitudinal section 154 is contiguous with a transverse locking section 156.
The biasing member 124 (not shown in
As best seen in
At the proximal end of the second casing 112 is a plunger guide slot or opening 166 extending through the second casing 112. The plunger guide slot 166 includes a transverse section 168 extending generally perpendicular to the longitudinal axis 130 (also described as extending horizontally) of the second casing 112. The transverse section 168 is contiguous with a longitudinal section 170 that extends longitudinally along the second casing 112 (also described as extending vertically). The plunger guide slot 166 is sized and shaped to received and guide a protrusion on the plunger slider 118. Unlike the plunger guide recess 134, the plunger guide slot 166 extends through the entire sidewall of the second casing 112. This provides a robust guiding alignment of the plunger slider 118 as well as a visual indication or verification of the location of the plunger slider 118 relative to the casing 108.
At a midsection of the second casing 112 are the protrusions 144 extending inwardly towards a center of the casing 108. The protrusions 144 support and centrally position the cartridge as will be explained subsequently. The second casing 112 also includes recesses 172 defined within the protrusions 144 for receiving and securing the flange of the barrel of a syringe, which is in turn supported in the cartridge 122. With the syringe barrel held in place by the recesses 172 (and generally held in a fixe position relative to the casing 108), the plunger slider 118 operates to distally depress the plunger of the syringe into the barrel and, thus, dispense the substance (e.g., drug) from the barrel of the syringe.
On a distal side of the protrusions 144 are distally-facing shoulders 174 that are oppositely positioned from the proximally-facing shoulders 146. The distally-facing shoulders 174 are sized and shaped to abut a portion of the cartridge 122 and to restrict proximal movement of the cartridge 122 within the casing 108.
Referring back to the proximal end, the second casing 112 includes a proximal cap 178 that encapsulates the proximal end of the casing 108 when the first and second casings 110, 112 are coupled together. At the midsection and at the distal end, the second casing 112 includes tabs 176 that jut outwards and are sized and shaped to couple with corresponding recesses on the first casing 110.
At a midsection of the cartridge 122 is a annular flange 192 in the shape of a frustoconical ring with a proximally-facing surface 194 that is generally perpendicular to a longitudinal axis of the cartridge 122. The proximally-facing surface 194 is joined by a distal-facing surface 196 that is angled or beveled so as to angle proximally. When the cartridge 122 is positioned within the casing 108, the annular flange 192 abuts against the distally-facing shoulders 174 of the protrusions 144. This abutment prevents proximal movement of the cartridge 122 within the casing 108. As such, once inserted into the casing 108, the cartridge is prevented from both proximal and distal movement therein via interaction of the annular flange 192 with the distally-facing shoulders 174 of the protrusions 144 (proximal movement) and interaction of the alignment fins 186 with the upper wall 192 of the protrusions that define part of the casing of the window 120.
As seen in
Coupled to and extending outward from the sidewall 220 of the cap 216 are first and second projections 230, 232. The first projection 230 is in the form of a four sided projection that is sized and shaped to fit and slide within the recess 134 defined partially on the first and second casings 110, 112. The second projection 232 is in the form of a post that is sized and shaped to fit and slide within the plunger guide slot 166 defined within the second casing 112.
As best seen in
It is noted that as the user applies the distal tub 114 to the injection site, the needle 262 enters the injection site as the tube 114 transitions from the extended state to the retracted state. In the retracted state, the needle 262 is positioned within the patient at the injection site. After dispensing of the drug from the syringe, the user pulls the injector 100 away from the injection site, which causes the distal tube 114 to extend into an extended and locked position.
When provided to the user with a pre-filled syringe 270 therein, the post 242 of the lock ring 126 is positioned at the start 158 of the track 148, as shown in
In this position, the needle 262 is exposed and would be in the injection site of the patient. In this position, the user would dispense the drug from the syringe 270 by depressing the plunger slider 118, which is shown in
In this way, the injector 100 can be used to dispense a drug one time before it is locked. That is, the injector 100 is provided for use that permits a single injection by the needle and a subsequent locking of the injector 100.
The foregoing merely illustrates the principles of the invention. Various modifications and alterations to the described embodiments will be apparent to those skilled in the art in view of the teachings herein. It will thus be appreciated that those skilled in the art will be able to devise numerous systems, arrangements and methods which, although not explicitly shown or described herein, embody the principles of the invention and are thus within the spirit and scope of the present invention. From the above description and drawings, it will be understood by those of ordinary skill in the art that the particular embodiments shown and described are for purposes of illustrations only and are not intended to limit the scope of the present invention. References to details of particular embodiments are not intended to limit the scope of the invention.
Claims
1. An injector for use with a syringe having a plunger, a barrel, and a needle, the injector comprising:
- a cartridge configured to support the syringe;
- a casing including first and second openings, an inner surface, an outer surface opposite the inner surface, and a track defined on the inner surface, the casing configured to support the cartridge and the syringe;
- a tube including a tube distal end, the tube slidably engaged with the cartridge and configured to extend and retract relative to the first opening of the casing, wherein, in a retracted state of the tube and with the casing supporting the cartridge and the syringe, the needle of the syringe extends beyond the tube distal end and the first opening of the casing;
- a biasing member engaged with the cartridge and the tube so as to bias the tube in an extended state of the tube;
- a ring including a protrusion, the ring engaged with the tube and the biasing member, the protrusion positioned at least partially within the track; and
- a plunger slider configured to couple to the plunger of the syringe and comprising a portion that is positioned outside the casing when the plunger slider couples to the plunger of the syringe, wherein, when the plunger slider and the plunger of the syringe are coupled together, movement of the portion of the plunger slider and the plunger are fixed.
2. The injector of claim 1, wherein the cartridge and the casing are removably coupled together.
3. The injector of claim 1, wherein the plunger slider extends at least partially through the second opening.
4. The injector of claim 3, wherein the second opening extends through a sidewall of the casing.
5. The injector of claim 4, wherein the second opening includes a linear section.
6. The injector of claim 5, wherein the second opening includes a transverse section proximal to the linear section.
7. The injector of claim 1, wherein the inner surface defines an internal volume, and the plunger slider is configured to engage with the plunger of the syringe within the internal volume of the casing.
8. The injector of claim 1, wherein the protrusion of the ring is positioned at least partially within the track and is configured to lock the tube in the extended position after the tube has been in the retracted state.
9. The injector of claim 1, wherein the ring is configured to rotate relative to the tube at least partially when the ring is engaged with the tube and the biasing member.
10. The injector of claim 1, wherein the casing is configured to support the cartridge and the syringe in a fixed position relative to the casing during movement of the plunger slider.
11. The injector of claim 10, wherein the barrel of the syringe includes a flange, and the inner surface of the casing includes a structure configured to contact the flange of the barrel of the syringe to facilitate the fixed position of the syringe relative to the casing during movement of the plunger slider.
12. The injector of claim 1, wherein movement of the plunger slider is independent of movement of the tube.
13. The injector of claim 1, wherein rotation of the plunger slider is inhibited once the plunger slider is moved distally.
14. The injector of claim 1, further comprising the syringe.
15. The injector of claim 14, further comprising a medicament housed within the syringe.
16. The injector of claim 1, further comprising a cap configured to releasably couple to an end of the casing.
17. The injector of claim 1, wherein the inner surface defines an internal volume, and the plunger of the syringe is positioned entirely within the internal volume of the casing.
18. The injector of claim 1, wherein the plunger slider comprises a proximal-facing engagement surface for use in at least assisting to moving the plunger slider distally.
19. The injector of claim 18, wherein the plunger slider further comprises a side-facing engagement surface for use in at least assisting to moving the plunger slider distally.
20. The injector of claim 1, wherein a rate of movement of the plunger slider is manually controlled.
21. A method of employing the injector of claim 1 having the casing supporting the cartridge and the syringe, and wherein the syringe includes a medicament therein, the method comprises:
- applying the tube to an injection site thereby causing the tube to be in the retracted state thereby causing the needle to enter the injection site;
- depressing the plunger slider at a user-controlled rate thereby causing dispensing of at least some of the medicament from the syringe into the injection site; and
- removing the tube from the injection site thereby causing the tube to be locked in the extended state shielding the needle.
22. The method of claim 21, wherein depressing of the plunger slider is independent of applying the tube to the injection site.
23. The method of claim 21, wherein depressing the plunger slider is performed at a user-controlled amount to dispense all the medicament.
24. The method of claim 21, wherein depressing the plunger slider is performed at a user-controlled amount to dispense less than all the medicament.
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Type: Grant
Filed: Dec 29, 2024
Date of Patent: Dec 2, 2025
Patent Publication Number: 20250135124
Assignee:
Inventors: Nicholas Love (Olathe, KS), Bradley Hopper (Topeka, KS)
Primary Examiner: Kevin C Sirmons
Assistant Examiner: Leah J Swanson
Application Number: 19/004,370